Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder.

Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder. A randomised flexible dose double-blind international multicentric study with parallel groups, versus fluoxetine (20 mg/day wi

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001668

Enrollment

Unknown

Registered

2011-11-01

Start date

2006-08-16

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Agomelatine:Oral Valdoxan, Agomelatine, 25 or 50mg, tablets

Fluoxetine:Oral Prozac, Fluoxetine, 20 or 40mg capsules

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Ambulatory male or female Asian patients aged from 18 to 65 years (both inclusive), fulfilling DSM-IV-TR criteria for MDD of moderate to severe intensity

Exclusion criteria

Exclusion criteria: 1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study without an effective contraception; 2. All types of depression other than major depressive disorder; 3. All other psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
Depression-Hamilton Depression Rating Scale 17 items: change from baseline to W8;	—

Secondary

Measure	Time frame
Depression-Clinical Global Improvement scale: change from baseline to W8;sleep-Leeds Sleep Evaluation Questionnaire (LSEQ) from W1 to W8;anxiety-Hamilton Anxiety Rating Scale (HAM-A) from baseline to W8;Tolerance-Emergence of adverse events, laboratory parameters, vital signs, electrocardiograms;	—

Countries

Singapore

Contacts

Public ContactProf. Shu Liang

shu-liang@126.com+86 10 82028364

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026